Hepatocellular CarcinomaNCT06333561
HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Lenvatinib, run by Sun Yat-sen University at 1 site in China.
Trial summary
Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitor
- What is being tested?
- Hepatic arterial infusion chemotherapy, Lenvatinib and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
Who may be able to join
- primary infiltrative HCC according to MRI or CT imaging characteristics.
- Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Lenvatinib as initial treatment.
- patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
- no history of other malignancies.
- no tumor thrombus in the atrium or vena cava.
Who cannot join
- HCC with tumor capsule.
- under 18 years or over 75 years.
- TACE as initial treatment.
- sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
- incomplete tumor imaging data.
- lost to follow-up after treatment within three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General hospital
Beijing, Beijing Municipality, 100853
Qunfang Zhou, Md, 8619868000115, zhouqun988509@163.com
Feng Duan, MD, 8613910984586, duanfeng@vip.sina.com
About this study
Official title: Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study
Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.
Read the detailed description
This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
- Conditions
- Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitor, Hepatic Arterial Infusion Chemotherapy
- Being tested
- Hepatic arterial infusion chemotherapy, Lenvatinib, Tislelizumab, Toripalimab, Sintilimab
- Keywords
- Hepatic arterial infusion chemotherapy, Tislelizumab, Toripalimab, Sintilimab, Camrelizumab, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic arterial infusion chemotherapyProcedure or surgery
Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.
LenvatinibDrug
12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day
TislelizumabDrug
200mg intravenously every 3 weeks
ToripalimabDrug
240mg intravenously every 3 weeks
SintilimabDrug
200mg intravenously every 3 weeks
CamrelizumabDrug
200mg intravenously every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| HAIC+Len+PD-1 inhibitor group | HAIC combined with Lenatinib and PD-1 inhibitor group Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: Tislelizumab; Drug: Toripalimab; Drug: Sintilimab; Drug: Camrelizumab | |
| Len group | Lenvatinib alone Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS is the length of time from the date of inclusion until death from any cause.
Measured: 24 months
Secondary outcomes (1)
Progression-Free-Survival
Progression was defined as progressive disease by independent radiologic review
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Jan 2021
- Primary completion30 Dec 2024
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Feng Duan, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333561
- Sponsor's protocol ID
- Liver Project 7
- Status last verified
- Feb 2025
- First submitted
- 21 Mar 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study
- ClinicalTrials.gov ID
- NCT06333561
- Acronym / sponsor ID
- Liver Project 7
- Conditions
- Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitor, Hepatic Arterial Infusion Chemotherapy
- Keywords
- Hepatic arterial infusion chemotherapy, Tislelizumab, Toripalimab, Sintilimab, Camrelizumab, Lenvatinib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.
Detailed description
This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC+Len+PD-1 inhibitor group | – | Procedure: Hepatic arterial infusion chemotherapy, Drug: Lenvatinib, Drug: Tislelizumab, Drug: Toripalimab, Drug: Sintilimab, Drug: CamrelizumabHAIC combined with Lenatinib and PD-1 inhibitor group |
| Len group | – | Drug: LenvatinibLenvatinib alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
Key inclusion criteria (6 listed)
- primary infiltrative HCC according to MRI or CT imaging characteristics.
- Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Lenvatinib as initial treatment.
- patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
- no history of other malignancies.
Key exclusion criteria (6 listed)
- HCC with tumor capsule.
- under 18 years or over 75 years.
- TACE as initial treatment.
- sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
- incomplete tumor imaging data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic arterial infusion chemotherapyHepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. | Procedure or surgery | HAIC+Len+PD-1 inhibitor group |
| Lenvatinib12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day | Drug | HAIC+Len+PD-1 inhibitor group, Len group |
| Tislelizumab200mg intravenously every 3 weeks | Drug | HAIC+Len+PD-1 inhibitor group |
| Toripalimab240mg intravenously every 3 weeks | Drug | HAIC+Len+PD-1 inhibitor group |
| Sintilimab200mg intravenously every 3 weeks | Drug | HAIC+Len+PD-1 inhibitor group |
| Camrelizumab200mg intravenously every 3 weeks | Drug | HAIC+Len+PD-1 inhibitor group |
Primary outcome
Overall survival
Time frame: 24 months
OS is the length of time from the date of inclusion until death from any cause.
1 secondary outcome
Progression-Free-Survival
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Duan, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Lenvatinib, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qunfang Zhou, MD (86 19868000115, zhouqun988509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.